You have HIV and you must start treatment today

Transcription

1 You have HIV and you must start treatment today Why must people newly diagnosed with HIV start treatment on the day of HIV Diagnosis? Jennifer Hoy Alfred Health and Monash University Disclosure of Interest Statement: Jennifer Hoy s institution has received reimbursement for her participation in Advisory Boards for Gilead Sciences, ViiV Healthcare and AbbVie. 1

2 What led to the emphasis on same day HIV diagnosis and initiation of ART by some jurisdictions? Reasons given to commence treatment same day as diagnosis Faster virological suppression therefore faster time to non-infectiousness Behaviour change at diagnosis In US, process of HIV testing, addressing social issues of housing, substance abuse, mental health, barriers to treatment finance/insurance for medications and care delays initiation of treatment resulting in disease progression and HIV transmission Linking people to care to ensure loss at each pillar/stage of the treatment cascade is minimized Same day HIV diagnosis and initiation of ART? Individual benefit of ART HIV prevention benefits BUT does treatment initiated same day as HIV diagnosis or 2-3 weeks later make any difference? What if the individual is not ready to start treatment personal informed decision 2

3 What is the evidence for same day treatment? Start in San Francisco RAPID trial Haiti South Africa Providing same day, observed ART to newly diagnosed HIV+ outpatients is associated with improved virologic suppression Christopher D. Pilcher, Hiroyu H. Hatano, Aditi Dasgupta, Diane Jones, Sandra Torres, Fabiola Calderon, Erin Demicco, Wendy Hartogensis, Clarissa Ospina-Norvell, Elvin Geng, Monica Gandhi, Diane Havlir University of California, San Francisco San Francisco General Hospital Pilcher et al, IAS,

4 The SFGH RAPID Model HIV+ Diagnosis Disclosure Referral Scheduling 1 st Clinic Visit Registered Insured Housing/SU /MH Counseling Labs 1 st Dcotor Visit Medical evaluation ART criteria met ART start Pills taken Viral load suppressed VL monitoring Adherence Retention RAPID visit: ART start Disclosure, counseling Registration Insurance Housing/SU/MH Labs Counseling Medical eval Doctor Visits VL monitoring ART mgment Adherence Retention Pilcher et al, IAS, 2015 RAPID Intervention Components Flexible scheduling for providers (on-call back-up) ART regimens pre-approved for use prior to genotyping or lab testing Available as 5 day starter packs Accelerated process for health insurance initiation Recommendation for 1 st dose to be taken observed in the clinic Multidisciplinary service including social support, HIV education, mental health counselling as well as laboratory tests. Programme counsellors assisted establishment of insurance coverage, Majority qualified for Medicaid Pilcher et al, JAIDS 2016 in press 4

5 RAPID Of 227 people newly diagnosed with HIV 39 participated in RAPID between July 2013 to Dec % of RAPID participants had acute HIV. 100% men, 59% black, 25% homeless, 0% with health insurance. Referred from public health testing sites, referred to the programme same day as receipt of diagnosis, in some cases this was days to weeks after taking the test. Provided with taxi vouchers to get to the clinic, Pilcher et al, JAIDS 2016 in press RAPID 90% opted to start ART same day, 5% the following day. All on therapy in a few weeks. 90% started with an integrase inhibitor regimen Virus suppression achieved in 56 days (c/w 119 days from historical cohort) 35/39 (90%) remained engaged in care at 6 months LTFU 10% no different to historical cohort Pilcher et al, JAIDS 2016 in press 5

6 Indicator Acceptability RAPID program era : at 18 months F/U RAPID (n=39) Universal (n=47) P value Overall ART uptake 39 (100%) 40 (85%) NS Engaged in care (appt <6 mos) 35 (90%) 40 (85%) NS Transferred care 8 (21%) 11 (23%) NS Provider switched 0 (0%) 0 (0%) NS Safety ART simplification 10 (26%) 0 (0%) ART Toxicity 2 (5%) 0 (0%) NS Genotype-driven modification 0 (0%) 0 (0%) NS Pilcher et al, JAIDS 2016 in press Time to VL suppression by ART initiation strategy: SFGH RAPID Universal ART CD4-guided ART Proportion <200 copies RAPID vs. universal ART P<0.001 Pilcher et al, JAIDS 2016 in press 6

7 Superior Outcomes with Same-Day HIV Testing and ART Initiation Serena Koenig, MD, MPH GHESKIO, Haiti Brigham and Women s Hospital, USA Reasons for Multiple Pre-ART Visits Concerns about missing TB and other OIs Concerns that patients will not be ready to start lifelong treatment Need to wait for test results (CD4 count) 7

8 Care Provided to Both Groups Same-day HIV counseling and testing, CD4 count, physician evaluation, CXR, ART readiness questionnaire Multiple clinician and counseling visits in the first month (same number for both groups) Monthly visits after first month Community health worker phone call/home visit for missed visits $US 1.70 per visit for transportation subsidy Schedule of Visits Standard group Days 7, 14, and 21: Physician/social worker visits Day 21: ART initiation Week 5: Physician/social worker visits Same-day ART group Day 1: Counseling and ART initiation Days 3, 10, and 17: Physician/social worker visits Day 24: Physician visit Only difference was timing of ART initiation 8

9 Screening and Enrollment 1255 patients with CD4 count 500 cells/mm 3 evaluated by HIV clinic physician on day of HIV testing; 434 had WHO Stage 3 or 4 disease or CXR consistent with TB 821 patients referred to study team on day of HIV testing 51 excluded for Stage 3 or 4 disease or prior ART 1 refused 7 failed ART readiness questionnaire 762 enrolled/randomized 51 transferred and excluded Analysis includes 564 enrolled by Feb Month Outcomes Standard Group (n=285) Same-Day ART Group (n=279) P-value Initiated ART 262 (92%) 279 (100%) p<0.001 Died 19 (7%) 8 (3%) p=0.035 Alive and in care 201 (71%) 224 (80%) p=0.007 In care with VL <50 copies/ml In care with VL <1000 copies/ml 120 (42%) 151 (54%) p= (50%) 171 (61%) p=0.008 Standard group: 15% LTFU and 8% late returners; same-day ART group 12% LTFU and 5% late returners 9

10 South African RapIT trial 377 patients recruited median CD4 count 210 cells late presenters Randomised to Rapid Intervention or standard Rapid intervention included point of care CD4 cell count, if eligible for ART, POC TB test, POC blood tests, physical exam, education, counselling and ART prescription 2.5 hours om clinic (then no waiting in long lines at pharmacy) By 90 days 97% in RapIT arm and 72% in standard arm commenced ART Rosen et al, PLoS Med

11 What does this trial tell us? By facilitating assessment and prescription more people will initiate ART early Still many barriers to early ART as seen in the exclusions in the trial BUT significantly greater numbers of people in the RapIT arm dropped out of care after the first visit c/w standard arm (13% vs 6%) they were not established on ART This means continuing adherence support essential after that initial visit How does this translate to Australia Feasibility of San Francisco, Haiti or South African approaches How many practices/clinics have the flexibility or luxury of providing same day 2.5 hours counselling, organizing housing, reviewing mental health/substance use issues, management of other social issues Availability of Point of care tests 11

12 How do these trials translate to Australia? How does this translate to Australia Excellent healthcare coverage (Medicare) and affordable ART (PBS) without restrictions ART offered to all HIV positive people Same day ART should be facilitated for those who request it ART initiation should occur when the individual is ready to start informed decision Most clinicians prefer being armed with baseline test results to individualize ART this takes 1-3 weeks this time does not make a significant difference to outcomes, either personal or HIV prevention 12